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Exelixis, Inc. (NASDAQ:EXEL) today announced updated results from BRIM7, an ongoing phase 1b clinical trial conducted by Roche and Genentech, Exelixis' collaborator and a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), of the BRAF inhibitor (BRAFi) vemurafenib in combination with the MEK inhibitor cobimetinib (GDC-0973/XL518) in patients with locally advanced/unresectable or metastatic melanoma carrying a BRAF
V600 mutation. Grant McArthur, M.D., Head of the Medical Oncology Skin and Melanoma Clinical Service at the Peter MacCallum Cancer Centre in Australia, and an investigator on the trial, presented the data today at the European Cancer Congress (ECC) 2013 (Abstract #3703) which is taking place in Amsterdam, The Netherlands.

“The data presented today, while early-stage, suggest that the preliminary safety profile and activity of the investigational combination of cobimetinib and vemurafenib is promising in BRAFi-naïve patients,” said Michael Morrissey, Ph.D., president and CEO of Exelixis. “Importantly, responses in these patients generally occurred early in their course of treatment. We are pleased with the progress Roche has made in advancing cobimetinib, and believe that this Exelixis-discovered compound warrants further study in melanoma, as people with this incurable disease desperately need new options.”

Exelixis received notice from Genentech in January 2013 that the first patient was dosed in a phase 3 pivotal trial (coBRIM) evaluating vemurafenib alone or in combination with cobimetinib in previously untreated patients with malignant melanoma harboring the BRAF
V600 mutation. This study is ongoing and currently enrolling globally. Top-line data from the trial are expected to be available next year.

Study Design

The phase 1b dose escalation study was designed to evaluate the safety and tolerability of cobimetinib in combination with vemurafenib. The dose escalation stage of the trial comprised 10 dosing cohorts of 3-6 patients and evaluated three different dosing schedules for the two active treatments. Cohorts that met the protocol-specified criteria for MTD were expanded and included BRAFi-naïve or vemurafenib-progressing patients.